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Timing of bowel irrigation could ease life after rectal cancer surgery

NCT ID NCT07696689

Symptom relief Sponsor: Simona Ascanelli Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 10, 2026 · Last updated Jul 10, 2026

Summary

This study looks at whether starting trans-anal irrigation (a procedure that uses warm water to help empty the bowel) within three months of stoma closure reduces daily bowel movements more than starting later. The trial involves 250 adults who have had rectal cancer surgery and now suffer from low anterior resection syndrome (LARS), which causes frequent, urgent, or uncontrolled bowel movements. Participants are trained to use a device at home and are followed for nine months to track symptoms, quality of life, and satisfaction.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Water-based transanal irrigation system (Peristeen® Plus device)
What this could lead to
If early irrigation works better, it could establish a new standard timing for managing bowel symptoms after rectal cancer surgery, improving daily comfort and quality of life.
What could go wrong
This is a mid-sized trial comparing two timing strategies, not a new treatment. The benefit may be modest, and individual results vary. The procedure requires daily commitment and may cause discomfort.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adults aged ≥ 18 years * Colorectal resection for rectal cancer with a protective ostomy * Integrity of the colorectal or coloanal anastomosis, as confirmed by each center's standard procedure * LARS score \> 30 (major LARS) * Not previously treated with TAI (except for enemas) * Completion of training on TAI irrigation by trained medical/nursing staff * Use of only the Peristeen® Plus device for TAI * Written informed consent Exclusion Criteria: * Neurological diseases * Psychiatric disorders * Refusal to consent to follow-up * Current or planned pregnancy * Known allergy to latex * Presence of contraindications as outlined in the device's Instructions for Use (IFU), such as ischemic colitis, acute inflammatory bowel disease, or acute diverticulitis.

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Conditions

The condition(s) this trial relates to.

constipation disorder Fecal Incontinence Low Anterior Resection Syndrome rectal neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Low anterior resection syndrome (LARS)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

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